Our website uses cookies to offer you a better browsing experience, analyse site traffic, personalise content, and serve targeted advertisements. By using our website you agree to our use of cookies. Please visit our Cookie Policy page for more information about cookies and how we use them

New regulations present Irish Healthcare with a significant opportunity to improve patient safety and drive down costs

Jul 27, 2017,
by Siobhain Duggan - Category: Pharma Serialisation

The opportunities and "unintended" benefits delivered by new EU and US healthcare regulations

Regulation is coming - the time to act is now. This was the key message from speakers at the Healthcare User Group (HUG) Information Day, hosted by the HSE at Cherry Orchard Hospital in Dublin. The event was attended by almost 100 delegates from across both hospitals and industry, including a significant delegation of pharmacists.

EU and US Regulations and Directives: Falsified Medicines and Unique Device Identification

The Healthcare User Group (HUG) information day focused on the regulatory requirements for the Falsified Medicines Directive (FMD) and the Unique Device Identification (UDI) regulation both of which will impact healthcare in Ireland. The event also focused on highlighting the opportunities and ‘unintended benefits’ of the regulations.

FMD - a point of dispense verification model

FMD is a point-of-dispense verification model that will require all manufacturers of prescription medicines to print a 2D Data Matrix barcode with serialisation data on each medicine pack. The information relating to each pack will be shared to a central repository and each pack will be decommissioned from the repository at the point-of-dispense. This will require significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies. The deadline for compliance is 9 February 2019. The resounding message from the speakers was to get involved, as this will affect all stakeholders.

Leonie Clarke from the Irish Medicines Verification Organisation (IMVO) (see IMVO formally established) encouraged the audience to “start thinking about what we can do with these barcodes. Both sets of regulations present Irish Healthcare with a significant opportunity to improve patient safety and drive down costs."

"By leveraging the Unique Identifier as mandated in regulation, a single business language can be developed that will enable the alignment of data between suppliers and hospitals,” said Vincent Callan, HUG Co-Chair and Director of Facilities, St. James’s Hospital, who opened the event.

Identifying and Tracking Medical Devices and Assets

The afternoon session focused on the Medical Device Regulation which includes UDI (Unique Device Identification). The session was chaired by John Swords, Head of Procurement for the HSE and HUG member. There were presentations from HPRA, DCC Vital, HSE Medical Devices, HSE Logistics and GS1 Global. Manufacturers selling medical devices in Europe are required to register their device information in the EUDAMED database by 2020, and from 2021 devices are required to have a UDI barcode on the product packaging. This is a phased approach similar to the FDA regulation, starting with Class III devices. The regulation will require manufacturers to include the UDI in the Field Safety Notices and recall notices being provided to the regulatory bodies in each country.

Ronnie McDermott, HSE Medical Equipment Management Lead confirmed the importance of the UDI for managing both medical equipment and medical devices. The EU UDI regulation also includes a requirement for healthcare providers to capture and store the UDI in their systems, preferably electronically, starting with Class III devices.

“The best unique identifier is the barcode and we see this as the single most reliable piece of information” said Brian Long, Assistant National Director HSE Procurement, who spoke about the work being done in the National Distribution Centre (NDC) to standardise information using the UDI/GTIN (Global Trade Item Number) as the unique identifier in the HSE systems. This will support compliance to contracts and traceability of product to the patient.